Debrief 发表于 2025-3-23 12:34:20

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Generator 发表于 2025-3-23 17:20:14

Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,La

雕镂 发表于 2025-3-23 20:04:01

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外来 发表于 2025-3-24 02:12:53

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Accolade 发表于 2025-3-24 05:20:43

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正式通知 发表于 2025-3-24 06:59:17

Process Qualification: Stage 2 of the FDA Process Validation Guidance,sing experimental design. The resulting process design experiments yield information that can be used to define future operating ranges for the new process. The second stage of process validation is process qualification.

摆动 发表于 2025-3-24 14:34:49

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ANIM 发表于 2025-3-24 18:14:57

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猛击 发表于 2025-3-24 21:10:17

Process Design: Stage 1 of the FDA Process Validation Guidance,This is the first of three chapters that describe statistical approaches related to the three stages of process validation described in the FDA Process Validation Guidance for Industry (2011). The three stages are

鼓掌 发表于 2025-3-25 01:29:40

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查看完整版本: Titlebook: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Indus; Richard K. Burdick,David J. LeBlond,